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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT® SET, ADMINISTRATION, INTRAVASCULAR

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RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT® SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 24321
Device Problems Fluid Leak (1250); Retraction Problem (1536)
Patient Problem Exposure to Body Fluids (1745)
Event Date 05/09/2019
Event Type  malfunction  
Event Description
Have had multiple issues regarding the vanishpoint blood collection set 23g and 25g. Needle did not retract into chamber and left exposed needle out for possible injury. Kept needle to view. "flash" was never given when in vein and almost caused patient to be recollected, 3 different patients today. Blood leaked out around needle (chamber area) and all over counter and gloved hands. Needle easily comes apart and fear exposure. Manufacturer response for greiner vanishpoint, greiner vanishpoint (per site reporter). Conference call friday (b)(6), clinical rep here on site yesterday afternoon to do observations of staff practice while using the device.
 
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Brand NameVANISHPOINT®
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
RETRACTABLE TECHNOLOGIES, INC.
511 lobo ln
little elm TX 75068
MDR Report Key8635529
MDR Text Key145913515
Report Number8635529
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2019
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number24321
Device Catalogue Number24321
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/21/2019
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer05/23/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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